Feasibility of Endosphenoidal Coil Placement for Imaging of the Sella During Transsphenoidal Surgery

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Background: Pituitary tumors can cause problems by secreting hormones in the body. They can also problems by growing large and pushing on organs near the pituitary gland. The best treatment for such tumors is to remove them by surgery. But that may be sometimes difficult. Some tumors maybe too small to see. Some other tumors maybe so large that portions maybe left behind during surgery. The endosphenoidal coil (ESC) is a new magnetic resonance imaging (MRI) device. It fits in a small space made during surgery near the pituitary. Researchers want to see if it helps transmit MRI signals during surgery to make better images of the pituitary gland and tumors.

Objective: To test the safety of using a new coil device to improve MRI imaging of pituitary tumors during surgery.

Eligibility: Adults 18-85 years old who are having pituitary tumor surgery at NIH

Design: Participants will be screened with: * Medical history * Physical exam * Review of prior brain scans * Blood and pregnancy tests All participants will have MRI of pituitary gland. They will lie on a table that slides into a metal cylinder in a strong magnetic field. They will lie still and get earplugs for loud sounds. A dye will be inserted into an arm vein by needle. Participants will stay in the hospital for about 1 week. They will repeat screening tests. Participants will have standard pituitary surgery. They will get medicine to go to sleep. The surgeon will create a path to the pituitary gland from under the lip. During surgery, the ESC will be placed through the path to near the pituitary. Then an MRI will be done during surgery. Then the ESC will be removed and standard surgery will continue. Participants will get standard post-operative care under another protocol.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

⁃ Adult subjects (more than 18 years of age) will be included in this study if they:

• Have a known or suspected tumor of the pituitary gland that requires surgical resection through a transsphenoidal approach. There is no size restriction. Invasion of surrounding anatomical structures by the pituitary tumor will not be ground for screen failure/withdrawal from study.

• Are enrolled in 03-N-0164, Evaluation and Treatment of Neurosurgical Disorders. If not enrolled, subjects will not be able to be included in the study as clinical and research procedures are done under the 03-N-0164 protocol.

• Are able to provide written consent.

• NIH employees are included in the study.

Locations
United States
Maryland
National Institutes of Health Clinical Center
RECRUITING
Bethesda
Contact Information
Primary
Michaela X Cortes
michaela.cortes@nih.gov
(301) 496-2921
Backup
Prashant Chittiboina, M.D.
prashant.chittiboina@nih.gov
(301) 496-2921
Time Frame
Start Date: 2019-05-09
Estimated Completion Date: 2028-12-01
Participants
Target number of participants: 70
Treatments
Experimental: 1
ENDOSPHENOIDAL COIL
Sponsors
Leads: National Institute of Neurological Disorders and Stroke (NINDS)

This content was sourced from clinicaltrials.gov